Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||4 Years - 70 Years|
Inclusion Criteria:1. If patients had receive immunotherapy, they should reach PR/NR, or recurrency. 2. Patients must be willing to sign an informed consent. 3. age: 4 to 70 years. 4. Estimated survival of ≥ 12 weeks, but ≤ 2 years. 5. Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A*0201 is required at the same time . 6. Subjects with solid tumor must have measureable disease. 7. Routine blood test：hemoglobin>=90 g/L; platelet>=50×10^9/L. 8. Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=50 ml/min. 9. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded) 10. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%. 11. ECOG score ≤2. 12. Adequate venous access for apheresis, and no other contraindications for leukapheresis. 13. Women of child-bearing age must have evidence of negative pregnancy test. 14. Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.
Exclusion Criteria:1. ECOG >= 3. 2. Patients with history of T cell tumors. 3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions. 4. Acute or chronic GVHD after allogeneic hematopoiesis. 5. steroid hormoneswere used before and after blood collection and infusion. 6. HIV infection or active hepatitis B or hepatitis C infection. 7. Uncontrolled active infection. 8. Enrolled to other clinical study in the last 4 weeks. 9. Subjects with systemic auto-immune disease or immunodeficiency. 10. Subjects with CNS diseases. 11. Other patients that researchers considered unsuitable for inclusion
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Shenzhen BinDeBio Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|B-cell Acute Lymphoblastic Leukemia, Lymphoma, Myeloid Leukemia, Multiple Myeloma, Hepatoma, Gastric Cancer, Pancreatic Cancer, Mesothelioma, Colorectal Cancer, Esophagus Cancer, Lung Cancer, Glioma, Melanoma, Synovial Sarcoma, Ovarian Cancer, Renal Carcinoma|
The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include ten different tumor-specific antibody.They are as following:anti-CD19 antibody for B cell leukemia and lymphoma;anti-CD22 antibody for B cell leukemia and lymphoma;anti-CD33 antibody for myeloid leukemia;anti-BCMA antibody for multiple myeloma;anti-CD38 antibody for multiple myeloma;anti-NY-ESO-1 antibody for multiple myeloma,esophagus cancer,lung cancer,melanoma and synovial sarcoma;anti-DR5 antibody for hepatoma;anti-C-met antibody for hepatoma,colorectal cancer,ovarian cancer and renal carcinoma;anti-EGFR V III antibody for hepatoma,lung cancer and glioma;anti-Mesothelin antibody for gastric cancer,pancreatic cancer and mesothelioma.
Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.
Biological: - CAR-T cell immunotherapy
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.